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临床试验/NCT04501601
NCT04501601已完成不适用

The Effect of Consuming on Body Composition and Blood Biochemistry Index

TCI Co., Ltd.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
TCI Co., Ltd.
入组人数
25
试验地点
1
主要终点
The change of body fat mass

研究概览

简要总结

To assess the effect of consuming on body composition and blood biochemistry index

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female aged between 20 and 60 years old
  • •Body mass index (BMI) ≥ 24 (kg/m^2) or body fat mass: male > 25%, female > 30%
  • •Prohibitions on other nutritional supplements (probiotics and prebiotics) before two weeks of the study
  • •Abidance by the similar diet and exercise habits over the study.

排除标准

  • •Pregnant or breastfeeding woman
  • •Menopausal woman
  • •Diabetes mellitus
  • •Implementation in weight loss programs before a half year of this study
  • •Metabolic disorders
  • •Kidney diseases
  • •Liver diseases
  • •Cardiovascular diseases
  • •Nervous system diseases
  • •Gastrointestinal diseases
  • •Heavy drinking or constant drug use.

研究组 & 干预措施

Experimental: weight loss program kit

Experimental

weight loss program kit

干预措施: Fruit and vegetable solid drink (Dietary Supplement)

结局指标

主要结局

The change of body fat mass

时间窗: Change from Baseline body fat mass at 2 months

The body fat mass (kg) was assessed by InBody770.

The change of Triglyceride

时间窗: Change from Baseline triglyceride at 2 months

Venous blood was sampled to measure concentrations of Triglyceride

The change of LDL-cholesterol

时间窗: Change from Baseline LDL-cholesterol at 2 months

Venous blood was sampled to measure concentrations of LDL-cholestrol

The change of HDL-cholesterol

时间窗: Change from Baseline HDL-cholesterol at 2 months

Venous blood was sampled to measure concentrations of HDL-cholestrol

Fecal microbiome analysis

时间窗: Change from Baseline Fecal microbiome at 2 months

Firmicutes, Bacteroidetes, Lactobucillius, and A. muciniphila were quantified by quantitative PCR.

The change of body mass index (BMI)

时间窗: Change from Baseline body mass index at 2 months

BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m\^2) and body mass (kg) were assessed by InBody770.

The change of visceral fat

时间窗: Change from Baseline visceral fat at 2 months

The visceral fat (10 cm\^2) was assessed by InBody770.

The change of Total cholesterol

时间窗: Change from Baseline total cholesterol at 2 months

Venous blood was sampled to measure concentrations of Total cholestrol

The change of body fat percentage

时间窗: Change from Baseline body fat percentage at 2 months

The body fat percentage (%) was assessed by InBody770

次要结局

  • The change of white blood cell(Change from Baseline white blood cell at 2 months)
  • The change of fasting glycemia(Change from Baseline fasting glycemia at 2 months)
  • The change of albumin(Change from Baseline albumin at 2 months)
  • The change of aspartate aminotransferase(Change from Baseline aspartate aminotransferase at 2 months)
  • The change of uric acid(Change from Baseline uric acid at 2 months)
  • The change of alanine aminotransferase(Change from Baseline alanine aminotransferase at 2 months)
  • The change of creatinine(Change from Baseline creatinine at 2 months)

研究者

发起方
TCI Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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